Stroke Oxygen Study Randomisation Form

Transcription

1 Identification sticker or Name Sex DOB male / female Unit No /Hiss No DD MM YYYY Stroke Oxygen Study Randomisation Form Trial Centre name Investigator name STEP ELIGIBILITY FOR TRIAL INCLUSION Time since admission with a clinical diagnosis of stroke (WHO criteria) more than 4h YES NO Time since stroke onset more than 48 h YES NO Expected to die within year from a non-stroke related illness YES NO Definite indication for continuous oxygen treatment YES NO Definite contraindication to continuous oxygen treatment YES NO Please proceed to patient details if all answers to Q are NO STEP PATIENT DETAILS Date and time of stroke onset dd-mm-yyyy hh:mm (4 h clock) Oxygen given in the ambulance no / not known / yes (for yes specify: 4% mask / 8% mask / 35% mask / 4% >4% mask / L/min via nasal cannula / 3L/min via nasal cannula / 4 L/min via nasal cannula/ >4l/min via nasal cannula) Oxygen given after arrival in hospital no / not known / yes (for yes specify: 4% mask / 8% mask / 35% mask / 4% >4% mask / L/min via nasal cannula / 3L/min via nasal cannula / 4 L/min via nasal cannula/ >4l/min via nasal cannula) Medical History Chronic obstructive airways disease or asthma [by history or from list of drugs] YES NO Other chronic lung problem [e.g. kyphoscoliosis, thoracoplasty, pneumoconiosis] YES NO Heart failure [by history, exam or > mg furosemide or equivalent per day] YES NO Ischaemic heart disease [history of angina or MI or treatment with nitrates or nicorandil] YES NO Atrial fibrillation YES NO Glasgow Coma Scale (please circle one response in each row) Eye opening None () To pain () To speech (3) Spontaneous (4) Motor Response None () Extension () Abnormal flexion (3) Withdrawal (4) Localizes to pain (5) Verbal resp. None () Incomprehensible () Inappropriate (3) Confused (4) Oriented (5) Obeys commands (6) STEP 3 PROGNOSTIC FACTORS (please circle the yes or no and complete oxygen saturation). Age (no need to enter here, will be calculated from DOB and date of stroke). Living alone before the stroke YES NO.3 Independent in activities of daily living before the stroke YES NO.4 Normal verbal response to questions (e.g. verbal Glasgow coma Scale Score=5) YES NO.5 Able to lift the affected arm against gravity YES NO.6 Able to walk unaided YES NO. Oxygen treatment prior to randomisation (ambulance or emergency department) YES NO 3. Oxygen saturation on room air at randomisation % 4. Blood glucose (result of BM stick suffices) mmol/l or g/dl SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. of

2 STEP 4 NIH Stroke Scale a Level of Consciousness (LOC) b LOC Questions c LOC Commands. Best Gaze 3. Visual Fields 4. Facial Palsy 5/6 Best Motor ARM 7/8. Best Motor LEG 9. Limb Ataxia. Sensory. Best Language. Dysarthria Alert keenly responsive Drowsy arousable by minor stimulation to obey, answer, or respond Stuporous requires repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (not stereotyped) 3 Comatose responds only with reflex motor or autonomic effects or totally unresponsive, flaccid Answers both correctly Answers one correctly Patient is asked to state the month & his/her age Both incorrect or no reply Obeys both correctly Obeys one correctly Patient is asked to open & close eyes, grip & release normal hand Both incorrect or no reply Normal Partial gaze palsy gaze is abnormal in one or both eyes, no forced deviation/total gaze paresis Forced deviation or total gaze paresis not overcome by oculocephalic maneouvre No visual loss (or in coma) Partial hemianopia Complete hemianopia 3 Bilateral Hemianopia including cortical blindness Normal Minor - flattened nasolabial fold, asymmetry on smiling Partial total or near total paralysis of lower face 3 Complete - absent facial movement in upper and lower face on one or both sides Right Left No drift holds limb at 9 degrees for full seconds Drift - drifts down but does not hit bed Some effort against gravity 3 3 No effort against gravity 4 4 No movement Right Left No drift holds limb at 45 degrees for full 5 seconds Drift - drifts down but does not hit bed Some effort against gravity 3 3 No effort against gravity 4 4 No movement Absent (or in coma) Present in limb Present in or more limbs 3 Normal Partial loss patient feels pinprick is less sharp or is dull on affected side Dense loss (or in coma) - patient is unaware of being touched on face, arm, leg No dysphasia Mild moderate dysphasia obvious loss of fluency or comprehension, without significant limitation on ideas expressed or form of expression. Makes conversation about provided material difficult or impossible, e.g. examiner can identify picture or naming card from patient's response. Severe dysphasia - all communication is through fragmentary expression; great need for inference, questioning, and guessing by the listener who carries burden of communication. Examiner cannot identify materials provided from patient response Mute no usable speech or auditory comprehension, or in coma. Normal articulation Mild moderate dysarthria - patient slurs some words, can be understood with some difficulty. Unintelligible or worse - speech is so slurred as to be unintelligible (absence of or out of proportion to dysphasia) or is mute/anarthric, or in coma 3. Neglect Total: No neglect (or in coma) Partial neglect - Visual, tactile, auditory, spatial, or personal inattention or extinction to bilateral simultaneous stimulation in one of the sensory modalities Complete neglect - Profound hemi-inattention or hemi-inattention to more than one modality. Does not recognise own hand or orients to only one side of space STEP 5 CONSENT. Fully informed consent YES NO. Patient does not disagree with trial YES NO 3. Consent from next of kin YES NO Before randomisation either OR and 3 must be answered as YES STEP 6 RANDOMISATION via or (day) or (after hours) Date and time of randomisation dd-mm-yyyy hh:mm (4 h clock) Randomisation number Print Name Sign and Date Monitor oxygen saturation 3 minutes after the start of treatment and 6 hourly thereafter. STEP 7 CONTACT preferred location for week follow-up if no longer in hospital at that time Clinic Home Other Not applicable (severe stroke, unlikely to be discharged by one week) SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. of

3 Stroke Oxygen Study Week (Assessment form) Name Randomisation no Home address: Home telephone no: NHS number Has the patient died? yes / no Date of death DD MM YYYY Please complete the Notification of Death Form (form 3) if the patient is deceased. Has the patient had serious adverse events? If yes, please complete SAE form (form 4) yes / no Oxygen administration for clinical indications during the 7 hour trial period: The patient was prescribed or received continuous oxygen for clinical indications The patient was not prescribed or given continuous oxygen for clinical reasons outside the trial treatment Compliance with oxygen treatment as prescribed for this study: Oxygen prescribed for 3 nights and signed in the drug chart as instructed Oxygen prescribed for 3 nights, but not signed as instructed (please explain ) Oxygen prescribed for 7 hours and signed as instructed Oxygen prescribed for 7 hours and not signed as instructed (please explain ) Oxygen stopped before the end of 3 days/nights (give reason) Reason for not completing prescribed oxygen treatment Patient is on the control group (no trial oxygen prescribed) Clinical data during the first week after trial inclusion: Antibiotics prescribed after randomization YES NO Thrombolysis performed YES NO Sedatives or antipsychotic drugs prescribed after randomizaton YES NO Highest temperature during week Other clinical trials: Has the patient been enrolled in any other clinical trials? YES / NO If yes, please specify give name of trial: SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. 3 of

4 Record of oxygen saturation and treatment during the first 3 days Please check compliance with treatment daily and make sure night staff is aware of the study and assessments if saturation or oxygen treatment has not been documented as instructed. Oxygen saturation at 4: (midnight) night Night staff checked and signed that oxygen is in place at 4: Oxygen saturation at 6 am night Night staff checked and signed that oxygen is in place at 6: Oxygen saturation at : (lunchtime) day Oxygen saturation at 4: (midnight) night Night staff checked and signed that oxygen is in place at 4: Oxygen saturation at 6 am night Night staff checked and signed that oxygen is in place at 6: Oxygen saturation at : (lunchtime) day 3 Oxygen saturation at 4:(midnight) night 3 Night staff checked and signed that oxygen is in place at 4: Oxygen saturation at 6 am night 3 Night staff checked and signed that oxygen is in place at 6: The highest oxygen saturation during the 3 days of trial treatment The lowest oxygen saturation during the 3 days of trial treatment The highest heart rate during the 3 days of trial treatment The highest systolic blood pressure during the 3 days of trial treatment The highest diastolic blood pressure during the 3 days of trial treatment YES / NO / CONTROL YES / NO / CONTROL YES / NO / CONTROL YES / NO / CONTROL YES / NO / CONTROL YES / NO / CONTROL CT /MRI diagnosis (please tick one of the boxes) Cerebral infarct Primary intracerebral haemorrhage Subdural haemorrhage Subarachnoid haemorrhage Brain tumour Head scan not performed Other (please specify) Second CT head scan (if performed) date (dd-mm-yyyy) New haemorrhage Yes / no Final diagnosis (Please make a final diagnosis using the clinical presentation, time course, head scan. Tick only one of the boxes) Ischaemic stroke TIA Primary intracerebral haemorrhage Cerebrovascular accident without CT confirmation of aetiology Other (Please specify) Is the patient still in hospital at day 7? YES/ NO If no, give date of discharge.. (DD-MM-YYYY) SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. 4 of

5 NIH Stroke Scale a Level of Consciousness (LOC) b LOC Questions c LOC Commands. Best Gaze 3. Visual Fields 4. Facial Palsy 5/6 Best Motor ARM 7/8. Best Motor LEG 9. Limb Ataxia. Sensory. Best Language. Dysarthria Alert keenly responsive Drowsy arousable by minor stimulation to obey, answer, or respond Stuporous requires repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (not stereotyped) 3 Comatose responds only with reflex motor or autonomic effects or totally unresponsive, flaccid Answers both correctly Answers one correctly Patient is asked to state the month & his/her age Both incorrect or no reply Obeys both correctly Obeys one correctly Patient is asked to open & close eyes, grip & release normal hand Both incorrect or no relpy Normal Partial gaze palsy gaze is abnormal in one or both eyes, no forced deviation/total gaze paresis Forced deviation or total gaze paresis not overcome by oculocephalic maneouvre No visual loss (or in coma) Partial hemianopia Complete hemianopia 3 Bilateral Hemianopia including cortical blindness Normal Minor - flattened nasolabial fold, asymmetry on smiling Partial total or near total paralysis of lower face 3 Complete - absent facial movement in upper and lower face on one or both sides Right Left No drift holds limb at 9 degrees for full seconds Drift - drifts down but does not hit bed Some effort against gravity 3 3 No effort against gravity 4 4 No movement Right Left No drift holds limb at 45 degrees for full 5 seconds Drift - drifts down but does not hit bed Some effort against gravity 3 3 No effort against gravity 4 4 No movement Absent (or in coma) Present in limb Present in or more limbs 3 Normal Partial loss patient feels pinprick is less sharp or is dull on affected side Dense loss (or in coma) - patient is unaware of being touched on face, arm, leg No dysphasia Mild moderate dysphasia obvious loss of fluency or comprehension, without significant limitation on ideas expressed or form of expression. Makes conversation about provided material difficult or impossible, e.g. examiner can identify picture or naming card from patient's response. Severe dysphasia - all communication is through fragmentary expression; great need for inference, questioning, and guessing by the listener who carries burden of communication. Examiner cannot identify materials provided from patient response Mute no usable speech or auditory comprehension, or in coma. Normal articulation Mild moderate dysarthria - patient slurs some words, can be understood with some difficulty. Unintelligible or worse - speech is so slurred as to be unintelligible (absence of or out of proportion to dysphasia) or is mute/anarthric, or in coma 3. Neglect Total No neglect (or in coma) Partial neglect - Visual, tactile, auditory, spatial, or personal inattention or extinction to bilateral simultaneous stimulation in one of the sensory modalities Complete neglect - Profound hemi-inattention or hemi-inattention to more than one modality. Does not recognise own hand or orients to only one side of space SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. 5 of

6 TOAST criteria (complete for infarcts only) Large-artery atherosclerosis (LAA) (tick this if there is Imaging evidence of >5% stenosis of intracranial or extracranial artery) Cardioembolism (CE) (Evidence of a medium-risk cardiac source of embolism and no other cause of stroke) Small-artery occlusion (lacunar infarct) (Clinically lacunar syndrome and lacunar infarct on CT and no evidence for ipsilat. LAA or CE) Acute ischaemic stroke of other determined aetiology (rare causes of stroke, such as nonatherosclerotic vasculopathies, hypercoagulable states, or haematological disorders and no evidence for LAA or CE ) Ischaemic stroke of undetermined aetiology (any patient who does not fit the above, e.g. fully investigated patients with > potential cause of stroke or patients who have not been fully investigated) Large-artery atherosclerosis (LAA) These patients will have clinical and brain imaging findings of either significant (>5%) stenosis or occlusion of a major brain artery or branch cortical artery, presumably due to atherosclerosis. Clinical findings include those of cerebral cortical impairment (aphasia, neglect, restricted motor involvement, etc.) or brain stem or cerebellar dysfunction. A history of intermittent claudication, transient ischaemic attacks (TIAs) in the same vascular territory, a carotid bruit, or diminished pulses helps support the clinical diagnosis. Cortical or cerebellar lesions and brain stem or subcortical hemispheric infarcts greater than.5cm in diameter on CT or MRI are considered to be of potential large-artery atherosclerotic origin. Supportive evidence by duplex imaging or arteriographay of a stenosis of greater than 5% of an appropriate intracranial or extracranial artery is needed. Diagnostic studies should exclude potential sources of cardiogenic embolism. The diagnosis of stroke secondary to large-artery atherosclerosis cannot be made if duplex or arteriographic studies are normal or show only minimal changes. Cardioembolism (CE) This category includes patients with arterial occlusions presumably due to an embolus arising in the heart. Cardiac sources are divided into high-risk and medium-risk groups based on the evidence of their relative propensities for embolism. At least one cardiac source for an embolus must be identified for a possible or probable diagnosis of cardioembolism stroke. Clinical and brain imaging finding are similar to those described for large-artery atherosclerosis. Evidence of a previous TIA or stroke in more than one vascular territory or systemic embolism supports a clinical diagnosis of cardiogenic stroke. Potential large-artery atherosclerotic sources of thrombosis or embolism should be eliminated. A stroke in a patient with a medium-risk cardiac source of embolism and no other cause of stroke is classified as a possible cardioembolic stroke. Small-artery occlusion (lacunar infarct) This category includes patients whose strokes are often labelled as lacunar infarcts in other classifications. The patient should have one of the traditional clinical lacunar syndromes and should not have evidence of cerebral cortical dysfunction. A history of diabetes mellitus or hypertension supports the clinical diagnosis. The patient should also have a normal CT/MRI or examination or a relevant brain stem or subcortical hemispheric lesion with a diameter of less than.5 cm demonstrated. Potential cardiac sources for embolism should be absent and evaluation of the large extracranial arteries should not demonstrate a stenosis of greater than 5% in an ipsilateral artery. Acute ischaemic stroke of other determined etiology This category includes patients with rare causes of stroke, such as nonatherosclerotic vasculopathies, hypercoagulable states, or hematologic disorders. Patients in this group should have clinical and CT or MRI findings of an acute ischaemic stroke, regardless of the size or location. Diagnostic studies such as blood tests or arteriography should reveal one of those unusual causes of stroke. Cardiac sources of embolism and large-artery atherosclerosis should be excluded by other studies. Ischaemic stroke of undetermined aetiology In several instances, the cause of a stroke cannot be determined with any degree of confidence. Some patients will have no likely aetiology determined despite an extensive evaluation. In others, no cause is found but the evaluation was cursory. This category also includes patients with two or more potential causes of stroke so that the physician is unable to make a final diagnosis. For example, a patient with a medium-risk cardiac source of embolism who also has another possible cause of stroke identified would be classified as having a stroke of undetermined aetiology. Other examples would be a patient who has atrial fibrillation and an ipsilateral stenosis of 5%, or the patient with a traditional lacunar syndrome and an ipsilateral carotid stenosis of 5%. Completed by : Print Name Sign and Date SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. 6 of

7 Stroke Oxygen Study Week (Contact form) For patients who were incompetent to sign consent at recruitment: Competent to sign today? Yes No If yes, explain study again and ask patient to sign patient confirmation of consent (after recovery) form. Preferred contact address and telephone number for the follow-up questionnaires: Name: Street and Number: Town, County, country: Postcode: Tel No: Mobile no: Alternative contact address and tel number if preferred address cannot be contacted: Name: Street and Number: Town, County, country: Postcode: Tel No: Mobile no: Address and telephone number of the patient's general practitioner: Name of GP: Street and Number: Town, County, country: Postcode: Tel No: Fax: Alternative follow-up arrangements if the patient is unable to complete the 3, 6 or month questionnaire or prefers a personal appointment: Clinic Appointment Other Please complete on line or fax the week assessment form the week contact form and the NIHSS score sheet for randomisation and week to ( ) Completed by : Print Name Sign and Date SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. 7 of

8 Stroke Oxygen Study Notification of Death (Assessment Form 3) Name Randomisation number: Date of Death Has the cause of death been confirmed by autopsy? Yes No Likely cause of death (tick one box only) Neurological damage due to the initial stroke Recurrent stroke Pneumonia Other infection Pulmonary Embolism Ischaemic heart disease Other cause of death (please specify) Completed by : Print Name Sign and Date SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. 8 of

9 Stroke Oxygen Study Serious Adverse Event Notification (Assessment Form 4) Please complete form below and fax to and ASAP within 4 hours of becoming aware of the event. Trial name: The Stroke Oxygen Study ISRCTN Report date and time (dd-mm-yyyy hh:mm) Date of Enrolment Centre name Country Randomisation number Date Age (years) Sex: Male/female Suspect treatment. tick the treatment you suspect as the cause of the adverse reaction: Oxygen L/min / 3L/min (please delete) inhaled via nasal cannulae Oxygen L/min / 3L/min (please delete) for 3 nights inhaled via nasal cannulae Control (room air) Event information When did this event happen with regard to the treatment phase? Before / During / After Is it a Serious adverse event? An adverse event is defined as serious if any of A-F has been answered with yes. Please describe the event regardless of your answer to A-F. If the answer to questions A-F is no in every case this is not a serious event - Please complete form (R & D-RF-SOS-) A. Did the event result in death? B. Is / was the event life threatening? C. Did / does the event lead to hospitalization or prolonged hospitalization? D. Did / does the event result in persistent or significant disability / incapacity? E. Did / does the event result in congenital anomaly / birth defect / carcinogenesis? F. Does the investigator consider the event a serious adverse event for other reasons A Date and time the Adverse Event began (dd-mm-yyyy hh:mm) Nature of event Intensity of event / Grading of Serious Adverse Event A Relationship to study drug(s) / Attribution of Serious Adverse Event A3 Action taken regarding study drug(s) A4 Clinical outcome Single / Multiple Episodes Mild / Moderate / Severe Definitely not/unrelated Unlikely / Possibly / Probably / Definitely / Unknown None Dose(s) missed Discontinued Recovered Not Yet Recovered Died SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. 9 of

10 B. Please describe the event in detail, providing any relevant medical information. i.e. pathology, radiology, ECG, bacteriology, biochemistry or clinical reports / information. SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. of

11 C. Assessment of event by local Investigator C. SAE category as adjudicated by local investigator (see attached SAE event categories for guidance) C. Do you consider this SAE unexpected i.e. a Suspected Unexpected Serious Adverse Reaction (SUSAR)? Form submission sign off - Enter your NAME: Date SAE Reported Time (4 hour clock) SAE Reported Have you checked that all entries above are correct? D. Assessment by the Chief Investigator Is this event considered an SAE by the Chief investigator or deputy? Is this event considered to be a SUSAR by the Chief investigator /deputy? If the answer to SUSAR is yes, do you want to send the report to MHRA/ COREC now Confirmation of date (dd-mm-yyyy) sent to MHRA/COREC Confirmation of time [4 hour clock] sent to MHRA/COREC Signature of Chief investigator: Follow-up report required Notes Date form was received by Trial Coordinating Centre (dd-mm-yyyy) SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. of

12 AE / SAE Event Categories v. To be used with SAE form v amendment (3. Aug.9) Cardiovascular Acute coronary syndrome (ACS) Atrial fibrillation (AF) Bradycardia Cardiac failure Cardiac dysrhythmia Chest pain Collapse Deep vein thrombosis (DVT) Hypertension Hypotension Myocardial infarction (MI) Pulmonary embolism (PE) Tachycardia Unstable angina Central nervous system Agitation Anxiety Cerebral oedema Complication of initial stroke Dementia Depression Dysphagia Extension of initial stroke Haemorrhagic transformation (of infarct, HTI) Headache Intracerebral bleed Intracranial/extracerebral bleed Recurrent stroke Sedation Seizure Sensory loss Transient ischaemic attack (TIA) Vertigo Visual loss Weakness Cutaneous Flushing Hypersensitivity inc. oropharangeal swelling, urticaria Rash Gastro-intestinal Abdominal pain Constipation Diarrhoea Dysphagia Gastrointestinal bleed Gastrointestinal disturbance Incontinence, faecal Heartburn Hepatitis Nausea Oral ulceration Pancreatitis Vomiting Weight loss Genito-urinary Sexual dysfunction Incontinence, urinary Renal impairment Urinary retention Urinary tract infection (UTI) Haematological Anaemia Leukopenia Methaemoglobinaemia Thrombocytopenia Immunological Anaphalactoid reaction Hypersensitivity Miscellaneous Acid base disturbance Bacteraemia Death unattended Diaphoresis Hyponatraemia Hypernatraemia Acidosis Extracranial bleeding (not GI haemorrhage) Fall Fatigue Hyperglycaemia Hyperuricaemia Infection (not otherwise specified) Malignancy Muscle twitching Vascular event (not otherwise specified) Respiratory Asthma Bronchospasm Chest infection Hypoxia Pneumonia Pulmonary embolism (PE) Shortness of breath Oxygen-related Respiratory depression Drying of mucous membranes Other (specify) SOS CRF vs amend 3 3.Aug.9 EudarCT COREC 6/Q ISRCTN p. of